Embolus Blood Clot Filter Utilizable With A Single Delivery System Or A Single Retrieval System In One of A Femoral or Jugular Access

ABSTRACT

A blood filter delivery system for delivering a filter into a vein from either a femoral or jugular access. The preferred system includes an introducer and a push-rod with a spline member disposed along the push-rod and a pusher member disposed on a distal end. The spline member has a main body, first and second boss portions spaced apart along the longitudinal axis to provide a gap for retaining anchor members of the filter during delivery via the introducer. In an alternative embodiment, a preferred filter includes first and second filter structures diverging in opposite directions. A link is connected to portions of each of the first and second filter structures so that each filter structure can be independently collapsed into a generally cylindrical shape.

PRIORITY DATA AND INCORPORATION BY REFERENCE

This application claims benefit of priority to U.S. Provisional PatentApplication No. 60/811,034, filed Jun. 5, 2006 which is incorporated byreference in its entirety.

FIELD OF THE INVENTION

Various embodiments described and illustrated herein relates to a bloodfilter device, delivery system, and retrieval system for such bloodfiltering device in a blood vessel.

BACKGROUND OF THE INVENTION

In recent years, a number of medical devices have been designed whichare adapted for compression into a small size to facilitate introductioninto a vascular passageway and which are subsequently expandable intocontact with the walls of the passageway. These devices, among others,include blood clot filters which expand and are held in position byengagement with the inner wall of a vein, such as the vena cava. Thesevena cava filters are generally designed to remain in place permanently.Such filters include structure to anchor the filter in place within thevena cava, such as elongate diverging anchor members with hooked endsthat penetrate the vessel wall and positively prevent migration ineither direction longitudinally of the vessel. The hooks on filters ofthis type are rigid, and within two to six weeks after a filter of thistype has been implanted, the endothelium layer grows over the diverginganchor members and positively locks the hooks in place. Any attempt toremove the filter results in a risk of injury to or rupture of the venacava.

A number of medical procedures subject the patient to a short-term riskof pulmonary embolism, which can be alleviated by a filter implant. Insuch cases, patients are often averse to receiving a permanent implant,for the risk of pulmonary embolism may disappear after a period ofseveral weeks or months. However, most existing filters are not easilyor safely removable after they have remained in place for more than twoweeks, and consequently longer-term temporary filters that do not resultin the likelihood of injury to the vessel wall upon removal are notavailable.

It is believed that most of the known filters are not capable of beingdelivered without regard for the orientation of the filter or accesssite. It is also believed that most of the known filters are not capableof being retrieved in either one of a femoral or jugular approach withone retrieval device.

One of the known filters, described and shown in U.S. Pat. No. 6,251,122issued to Tsukernik, utilizes a plurality of strands with a slidingmember slidingly disposed about a portion of the strands. Recovery ofthis filter, however, is believed to require two different devicesapproaching from both the femoral and jugular access sites as shown inFIG. 4 of this patent.

Another known filter, described and shown in U.S. Pat. No. 6,443,972 asa somewhat symmetrical filter. However, this filter, like others, canonly be retrieved from one access site.

Applicants have recognized that biological anatomies may vary such thataccess from the jugular may be inappropriate or that access from afemoral site is similarly inappropriate. For example, in the knownfilter delivery system, if the jugular (or femoral) site isinappropriate for delivery and the delivery system of a known filter canonly be utilized from the jugular (or femoral) approach then theclinician would have to obtain a femoral (jugular) delivery system. Toprovide immediate access to an alternative delivery device during aprocedure, this would require the clinician to have two systems in theclinical inventory prior to the procedure. Similarly, in the knowndelivery system, if the retrieval is inappropriate for the jugular (orfemoral) approach then the clinician would have to obtain a femoral (orjugular) retrieval system prior to the procedure. Immediate access toone or the other retrieval systems would require a clinical inventory oftwo different retrieval systems prior to the procedure. Hence,applicants have recognized the desirability for a blood filter systemthat addresses one or more of the above issues.

SUMMARY OF THE INVENTION

The various embodiments provide for a blood filter utilizable with ablood filter delivery or retrieval system that resolves potentialproblems of the known delivery system and filter and have thereforeadvance the state of the art in blood filter designs, blood filterdelivery and retrieval techniques.

In one embodiment, a blood filter is provided that includes first andsecond filter structures, and a link. The first and second filterstructures diverge away from a longitudinal axis in opposite directionsin a first configuration of the filter structures. The link is connectedto discrete portions of each of the first and second filter structuresso that each filter structure is independently collapsed into agenerally cylindrical shape in a second configuration.

In yet another embodiment, a delivery catheter sheath for a blood filteris provided that includes a generally tubular member. The generallytubular member has a first end, intermediate end and a second enddefining a longitudinal axis extending therethrough. The first end hasan inner surface exposed to the longitudinal axis; the inner surface hasa plurality of notches formed on the inner surface; the intermediate endincludes a boss portion disposed in the tubular member, which has aplurality of grooves formed in the boss portion.

In a further embodiment, a blood filter retrieval device is providedthat includes first and second generally tubular members, a collapsiblemember and a retrieval member. The first generally tubular memberextends from a first end to a second end to define a longitudinal axisextending therethrough. The second generally tubular member can bedisposed generally coaxially with the first generally tubular member.The collapsible member can be coupled to the second generally tubularmember that defines a portion of a cone in one configuration and acylinder in another configuration. The retrieval member can be disposedin the second tubular member and the collapsible member.

In yet another embodiment, a blood filter system is provided thatincludes an introducer, pusher assembly, and a blood filter. Theintroducer may have a coupling port connected to an elongated generallytubular member. The pusher assembly may have a first end disposed in thestorage member and a second end extending out of the Y-adapter andfurther include a handle disposed along a longitudinal axis of thepusher assembly proximate the second end; a pusher disposed along thelongitudinal axis proximate the first end of the elongated assembly; anda generally tubular member having a first end, intermediate end and asecond end defining a longitudinal axis extending therethrough, thefirst end having an inner surface exposed to the longitudinal axis, theinner surface having a plurality of notches formed on the inner surface,the intermediate end including a boss portion coupled to the pusher anddisposed in the tubular member having a plurality of grooves formed inthe boss portion, the first end coupled to the Y-adapter. The bloodfilter may include at least a first anchor member having hooks disposedin one of the grooves and notches; and at least a second anchor memberhaving hooks disposed in the other of the grooves and notches.

In yet an alternative embodiment, a blood filter kit is provided thatincludes a delivery system, blood filter, and instructions for use. Thedelivery system includes: an introducer having a coupling port connectedto an elongated generally tubular member; a dilator configured to beinserted into the introducer to dilate a vessel; a pusher assemblyhaving a first end disposed in the storage member and a second endextending out of the Y-adapter and further having: a handle disposedalong a longitudinal axis of the pusher assembly proximate the secondend; a pusher member disposed along the longitudinal axis proximate thefirst end of the elongated assembly; and a generally tubular memberhaving a first end, intermediate end and a second end defining alongitudinal axis extending therethrough, the first end having an innersurface exposed to the longitudinal axis, the inner surface having aplurality of notches formed on the inner surface, the intermediate endincluding a boss portion coupled to the pusher and disposed in thetubular member having a plurality of grooves formed in the boss portion,the first end coupled to the Y-adapter. The blood filter includes atleast a first anchor member having hooks disposed in one of the groovesand notches; at least a second anchor member having hooks disposed inthe other of the grooves and notches. The instructions on how to deliverthe blood filter to a site in a human readable graphical and textualformat using the delivery device.

In yet a further embodiment, a method of delivering a blood filter fromeither an incision in the femoral or jugular vessels is provided. Themethod can be achieved by providing a filter, storing such filter,accessing an implant site, and releasing the filter from the sheathproximate the implantation site to engage the filter structures againsta vessel wall of the implantation site. The blood filter may have firstand second filter structures that diverge away from a longitudinal axisin opposite directions in a first configuration with a link connected todiscrete portions of each of the first and second filter structures sothat each filter structure is independently collapsed into a generallycylindrical shape in a second configuration. The filter is storedproximate a distal end of a generally tubular sheath having a first end,intermediate end and a second end defining a longitudinal axis extendingtherethrough. The first end may have an inner surface exposed to thelongitudinal axis. The inner surface may have a plurality of notchesformed on the inner surface. The intermediate end includes a bossportion coupled to the pusher and disposed in the tubular member havinga plurality of grooves formed in the boss portion. The implantation sitemay be accessed via one of the femoral or jugular vessels.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutepart of this specification, illustrate presently preferred embodimentsof the invention, and, together with the general description given aboveand the detailed description given below, serve to explain features ofthe invention.

FIG. 1 illustrates exemplarily a first embodiment of a blood filter.

FIG. 2A illustrates exemplarily a second embodiment of a blood filter.

FIG. 2B illustrates exemplarily a plurality of embodiments of the bloodfilter.

FIG. 3 illustrates a delivery system for one of the embodiments of bloodfilter including instructions for use embodied in paper form.

FIG. 4 illustrates one of the filters as disposed in the sheath of thedelivery system in a close up view.

FIG. 5 illustrates a distal end of the sheath in which various retentionmembers of the filter are located in notches.

FIG. 6A illustrates a proximal end of the sheath in which variousretention members of the filters are located in a splined member, whichis not part of the filter.

FIG. 6B illustrates a splined member that is part of the filter.

FIG. 6C illustrates yet another splined member that is part of thefilter with a recovery member provided on the splined member.

FIG. 7 illustrates, in a close up view, one embodiment of a retentionmember.

FIGS. 8A and 8B illustrate details of another embodiment of a deliverysheath for a filter delivery system.

FIGS. 9A-9I illustrate exemplarily a high level overview of a filterretrieval process using one embodiment of a retrieval system.

FIGS. 10A-10B illustrate exemplarily a high level overview of yetanother filter retrieval process using a second embodiment of theretrieval system.

FIGS. 11A-11B illustrate exemplarily a high level overview of anotherfilter retrieval process using a third embodiment of the retrievalsystem.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following detailed description should be read with reference to thedrawings, in which like elements in different drawings are identicallynumbered. The drawings, which are not necessarily to scale, depictselected embodiments and are not intended to limit the scope of theinvention. The detailed description illustrates by way of example, notby way of limitation, the principles of the invention. This descriptionwill clearly enable one skilled in the art to make and use theinvention, and describes several embodiments, adaptations, variations,alternatives and uses of the invention, including what is presentlybelieved to be the best mode of carrying out the invention.

As used herein, the terms “about” or “approximately” for any numericalvalues or ranges indicate a suitable dimensional tolerance that allowsthe part or collection of components to function for its intendedpurpose as described herein. Also, as used herein, the terms “patient”,“host” and “subject” refer to any human or animal subject and are notintended to limit the systems or methods to human use, although use ofthe subject invention in a human patient represents a preferredembodiment.

FIGS. 1-11 illustrate one of many exemplary embodiments. In an overview,as shown in FIG. 3, a blood filter system 100 includes a Y-adapter 10,catheter sheath 15 containing the filter 14, a catheter-like introducer16 and a pusher assembly 12 to push the filter 14 from the cathetersheath 15, through the introducer 16 and then into the blood vessel. Forconvenience in illustrating the preferred embodiments, the blood filtersystem 100 has various components that can be referenced to an imaginarylongitudinal axis A-A. Each system is preferably packaged as a “kit”with instructions-for-use IFU for sale to a clinician. Each component ofthe blood filter system is described in greater detail below.

Referring back to FIG. 1, one exemplary embodiment of the blood filter14 is illustrated in its first or operational configuration in a bloodvessel BV, which has a blood vessel wall BVW disposed about a blood flowpath BF.

As implanted, the blood filter 14 may include first and second filterstructures 14 a and 14 b that diverge away from a longitudinal axis A-Ain opposite directions in the implanted configuration, as shown here inFIG. 1. First filter structure 14 a may have at least two anchor members14 a 1 and 14 a 2. Similarly, second filter structure 14 b may have atleast two anchor members 14 b 1 and 14 b 2. Each of the anchor memberscan include a retention member 14 h disposed at a terminal end thereof,such as, for example, a barbed hook, a curved hook or a double barbedhook.

In the preferred embodiments, the first and second filter structures canbe integrated with each other. For example, with reference to FIG. 1, asingle wire can be configured to have three sections: a first sectiondefining a portion of the first filter structure, a middle sectiondisposed proximate the longitudinal axis, and a second section defininga portion of the second filter structure. As such, for a filterutilizing four anchor members for each of the filter structures, fourwires can be utilized. The wires can be bent into the first section,middle and second sections and joining the respective middle sections ofthe wires together. At the junctures J1 and J2 for the middle and firstsections and middle and second sections, a small radius of curvature canbe provided to reduce stress concentration at the respective juncturesJ1 and J2 in the wire. Although the term “wire” herein is utilized todenote an elongated member having a generally circular cross-section,other members formed by suitable techniques with differentcross-sections can be utilized. For example, a plurality of wires can beformed by extrusions or by laser cutting a thin tubular form. In thepreferred embodiments, a shape memory material such as, for example,Nitinol can be utilized. Other materials can be used instead of Nitinol,such as, for example, shape memory materials (e.g., copper alloy systems(Cu—Zn; Cu—Zn—Al) and alloys of Au—Cd, Ni—Al, Fe—Pt, or shape memorystainless steel), shape memory composites, weak shape memory metals(e.g., stainless steel, platinum, Elgiloy), shape memory polymers,bioresorbable metals, polymers, piezoelectric ceramics (e.g. bariumtitanate, lead zirconate to name a few), piezoelectric composites,sputter deposited Ni—Ti films, magnetostrictive materials, magneticshape memory materials, nanocomposites, electroactive polymers thatundergo shape change in the presence of voltage potentials.

In the preferred embodiments, the wire can be a material selected from agroup consisting essentially of shape memory material, super-elasticmaterial, linear-elastic material, metal, alloys, polymers andcombinations thereof. Preferably, the wire has a cross-sectional area ofabout 0.00013 squared inches.

Instead of joining the wires together proximate the middle sections ofthe wires, a hub 50 can be utilized to constrain the plurality of wiresforming the first and second filter structures, as shown here in FIG. 1.Hub 50 can be coupled to the middle sections by a suitable couplingtechnique such as, for example, swaging, crimping, welding, bonding,gluing. Hub 50 can be a porous polymer loaded with suitable bio-activeagents for elution once filter 14 has been implanted.

Instead of making the filter out of wires, a blood filter of generallythe same configuration can be cut out from a thin tubular member using asuitable cutting technique such as, for example, laser cutting (asdescribed and shown in U.S. Pat. No. 6,099,549, which is incorporated byreference herein in its entirety), electric-discharge machining or viaetching.

Each of the filter structures 14 a and 14 b preferably respectively hasa link 30 a and link 30 b, as shown in FIG. 1, which allows each of thefilter structures 14 a and 14 b to be independently collapsed into agenerally cylindrical shape in a second or non-operationalconfiguration. The link preferably includes an elongated memberconnected to the first section of each wire of the first filterstructure via a suitable connection, such as, for example, a welded, ora swivel coupling SC, shown here in FIG. 7 with boss portions N1 and N2to constrain link 30 a to anchor portion 30 d via a circular hoop N3 sothat as a force F is applied, link 30 a and anchor 30 d rotate relativeto each other. That is, the swivel coupling SC allows the link 30 a andwire or anchor 30 d to rotate relative to each other. Where a hingedconnection is desired, a super-elastic coupling SH can be employed inplace or interposed between link 30 a and loop N3 of the swivelcoupling. The super-elastic coupling SH can be, for example, a superelastic hinge such as one shown and described in U.S. Pat. No. 5,776,162to Kleshinski, issued Jul. 7, 1998, which document is hereinincorporated by reference in its entirety. Alternatively, a slidingcoupling can be utilized by integrating N1, N2 and N3 together andconfiguring these members to slide and rotate with respect to anchor 30d. In yet a further alternative, the super-elastic coupling SH can beintegrated with the sliding coupling.

Referring again to FIG. 1, one or both of the links 30 a, 30 b for thefilter structures 14 a, 14 b can include another elongated memberconnected to the first section of each wire of the filter structures 14a, 14 b. More specifically, one or both of the links 30 a, 30 b can berespectively connected to a hub 32 a, 32 b. The hubs 32 a, 32 b arepreferably located substantially along the longitudinal axis A-A.Although each of the first and second filter structures are illustratedas having at least two elongated members, it is within the scope of thisdisclosure to have a single unitary link connecting all of the anchormembers (e.g., 2-8 anchor members) together to allow the anchor membersto be configured into the collapsed shape such as, for example, shown inFIG. 3.

Each link can be coupled to the anchor member anywhere along the lengthof the anchor member including any portions proximate the hook 40.Preferably, the link is anchored at a suitable distance from the hook 40so that tissue in-growth does not substantially prevent the link fromswiveling or pivoting. In a preferred embodiment, the link can be madeout of a material other than the material or materials in which thefilter anchor member is made of. For example, the link can be made outof suture material (resorbable and non-resorbable type) or carbonnanotubes or metal wire.

Variations of the filter 14 can be utilized by a clinician for deliveryand extraction. For example, as shown in FIG. 2A, the links areinterconnected via a third link 30 c extending through hollowed hub 50so that upon full collapsing of one filter section will lead to thepartial or full collapse of the other filter section. That is, one linkis interlocked to the other link. Additionally, the hub 32 a or 32 b canbe provided with a retrieval member 32 c or 32 d for this embodiment.

Several alternative configurations are exemplarily illustrated in FIG.2B. In a first configuration, anchor member 140 a can be a partiallyhollow tube with retention member 400 disposed in a telescopic manner.The retention member 400 is preferably provided with a hook 40 that canbe straightened as the anchor member 140 a is pulled into the tube by aspline member 33. In this configuration, the links 30 a are connected toretractable super elastic hooks 42 for respective anchor members, whichcan range in quantity from 3, 4, 6, 8 or 12 members. The connectionallows the hooks to be partially or even fully retracted into hollowanchor members 14 a 1, 14 a 2, 14 a 3, 14 a 3 when the spline member 33(or nub 32A) is pulled or pushed along the longitudinal axis. Anotherembodiment is also illustrated in which the retention member 400 a doesnot utilize smaller cross-sectional area hook 402 as with hook 40.Instead of curved hooks, another embodiment would include linearlyangled member 404. Alternatively, more than one linearly angled member404 can be used as shown here with members 404 a and 404 b. In yet afurther embodiment, an arrow shaped retention member 406 can beutilized.

In the preferred embodiments, retention member 14 h is a curved hook 40that extends for at least forty-five degrees (45°) about a center, andin one variation, the hook can subtend for more than three hundred andsixty degrees (360°) about a center. In the preferred embodiments, thehook 40 can be made from material selected from a group consistingessentially of shape memory material, super-elastic material,linear-elastic material, metal, alloys, polymers and combinationsthereof.

Most preferably, the hook 40 is of the configuration shown in FIG. 7with a proximal hook portion 40 p and a distal hook portion 40 d onwhich a sharpened tip 40 t is provided. The hook 40 can be formed tohave a thickness t₃. Where the hook 40 is formed from a wire having agenerally circular cross-section, the thickness t₃ may be generallyequal to the outside diameter of the wire. In an embodiment, the hookthickness t₃ is approximately 0.5 to approximately 0.8 that of theanchor thickness t₂. The wire can be configured to follow a radius ofcurvature R₂ whose center is located at longitudinal distance L11 andradial distance d9 when the filter is at the temperature of a subject,as discussed above. The tip 40 t can be provided with a generally planarsurface whose length can be approximately equal to length h₁. The tip 40t may be located over a distance h₂ from a plane tangential to thecurved portion 40 s. Preferably, the hook is a curved member having across-sectional area of about 0.000086 squared inches (in.²).

Of particular interest is the ability of the preferred hook to take on acurved configuration in an operative condition and towards a generallylinear configuration in another condition when axial force is appliedalong the length of the wire. Details of this ability of the hook (andthe pusher assembly along with a similar catheter assembly) are shownand described in U.S. Pat. No. 6,258,026 issued Ravenscroft et al onJul. 10, 2001; U.S. Pat. No. 6,007,558 issued to Ravenscroft et al onDec. 28, 1999, provisional application Ser. No. 60/680,601 filed on May12, 2005, and as well as in a PCT Patent Application that claimspriority to the antecedent provisional patent application, which PCTPatent Application is entitled “Removable Embolus Blood Clot Filter,”having PCT Application No. PCT/US06/17889 filed on May 9, 2006, whichdocuments are incorporate herein by reference in their entirety.

The filter 14 can be delivered or implanted using a delivery system 100,illustrated in FIGS. 3-6A that includes a catheter sheath 15 containingthe filter 14. Components of the system include an adapter, such as aY-adapter, and in particular, a Touhy-Borst Adapter 10 (FIG. 3), acatheter sheath 15 (FIG. 5) coupled to the Touhy-Borst Adapter 10 with afilter 14 stored in the catheter sheath 15, and provided with anelongated pusher assembly 12 that can be used to deploy the filter 14 ina blood vessel of a mammal. Other components that can be used with thesystem include a catheter introducer 16 and a catheter dilator 18.

Referring to FIG. 3 and FIG. 5, the delivery catheter sheath 15 caninclude a generally tubular member having a first end 15 a, intermediateend 15 b, and a second end 15 c (FIG. 3) defining a longitudinal axisA-A extending therethrough the generally tubular member 15 d. The firstend 15 a preferably has an inner surface 15ID exposed to thelongitudinal axis, where the inner surface 15ID has a plurality ofnotches 15 a 1, 15 a 2, 15 a 3 formed on the inner surface 15ID (FIG.5). The plurality of notches 15 a 1-15 a 3 are preferably configured toengage the hooks 40 of the anchor members 14 a 1-14 a 4 to facilitatesymmetrical loading of the filter 14. To provide for the plurality ofnotches 15 a 1-15 a 3, the first end 15 a is preferably enlargedcompared to the remainder of the tubular member 15 d. Elimination of theenlarged end 15 a can provide for an optional lower profile sheath 15 ininstances where symmetrical loading is not necessary.

The intermediate end 15 b (FIG. 6A) may include a boss portion 20 adisposed in the tubular member 15 having a plurality of grooves 20 cformed in the boss portion 20 having a truncated conical surface 20 e onwhich filter hooks 40 (with only one shown for clarity in FIG. 6A) canbe mounted thereon with a portion of transition portion 14 ab beingsecured in the groove 20 c. Each groove 20 c of can be provided with aplurality of widths along a longitudinal length of the groove to providefor various gaps in the groove. The anchor portion of the filter 14 isconfigured to have a maximum width greater than a minimum width of thegroove 20 c so that the anchor portion is limited in its longitudinalmovement in groove 20 c. This feature allows for the splined boss 20 tomove anchor portion 14 b in the distal direction (leftward in FIG. 6A)when splined boss 20 is moved distally (leftward in FIG. 6A).

The splined boss 20 can be connected to the pusher 12 so that axialmovement of the pusher distally would cause the filter 14 to be pushedout of catheter sheath 15 for delivery into the blood vessel. Thesplined boss 20 may be provided with an opening 20 d so that nub 32 a or32 b can be inserted into the opening while the filter 14 is in apre-delivery configuration in sheath 15. Alternatively, the cathetersheath 15 may include a housing or body coupled at the second 15 c endof the sheath 15 while an elongated member 12 can be used to push a bossportion 20 b, which is part of the filter (FIG. 6B). In yet a furtheralternative, a boss portion 20 b 1 (which is part of filter 14) can beprovided with a retrieval member 21 as shown, for example, in FIG. 6C.

Each of the various embodiments of the splined boss 20 is utilized tomaintain the hooks 40 in a non-interference configuration, i.e.,non-crossed configuration, while the filter 14 is in the sheath 15. Inthese embodiments, the splined boss is utilized to transmit motion inthe distal direction from the handle 12 a into the anchor members 14 a1, 14 a 2, and 14 a 3 and so on during delivery of the filter out of thesheath 15 into the blood vessel. The splined boss achieves this byhaving various cross-sectional areas of the groove 20 c where at leastone cross-sectional area of the groove is smaller than the smallestcross-sectional area (e.g. 14 ab) of the anchor member 14 a 1 (butexclusive of the cross-sectional area of the hooks 40, which is smallerthan any of the above). Further, where the splined boss is integral withthe pusher 12, the boss is designed so that movement of the splined boss20 in the proximal direction while in the sheath 15 is restrained sothat substantial inadvertent movement of the pusher 12 in the proximaldirection does not result in the filter 14 being pulled towards theY-adapter 10.

In the configurations of FIG. 3, the elongated member 12 extends fromthe one end through another end of the body to provide a portion thatcan be utilized as a handle 12 a. In the preferred embodiments, the bodyis a Y-adapter 10 with a marker disposed proximate the first end of thesheath. The elongated member 12 includes a generally cylindrical member12 b having at least two different cross-sectional areas, e.g., a largerdiameter portion. For example, distal of the handle 12 a, the elongatedmember 12 can have a stainless steel tube (not shown) disposed about thecylindrical member 12 b to allow for sufficient rigidity while beinghandled by a clinician while still allowing for flexibility proximatethe tip when navigating a tortuous blood vessel. Also preferably, thesheath 15 includes a polymeric tube having at least two different Shoredurometer of hardness proximate one of the first and second ends.

The hooks of the preferred embodiments allow for removal of the filter14 with minimal injury to a blood vessel. In particular, with referenceto FIG. 7, the hook 40 can be provided with a proximal hook portion 40 pand a distal hook portion 40 d on which a sharpened tip 40 t isprovided. The hook 40 can be formed to have a thickness t3. Where thehook 40 is formed from a wire having a generally circular cross-section,the thickness t3 may be generally equal to the outside diameter of thewire. In an embodiment, the hook thickness t3 is approximately one-halfthat of the anchor thickness t2. The wire can be configured to follow aradius of curvature R2 whose center is located at longitudinal distanceL11 and radial distance d9 when the filter is at the temperature of asubject, as discussed above. The tip 40 t can be provided with agenerally planar surface 40 d whose length can be approximately equal tolength h1. The tip 40 t may be located over a distance h2 from a planetangential to the curved portion 40 s. Preferably, the radius ofcurvature R2 is about 0.03 inches and the thickness t2 of the anchormember is about 0.013 inches.

Once implanted, the hooks 40 may be removed from the Inferior Vena Cava(“IVC”) wall during filter removal procedure when longitudinal force isapplied to the hub 50 in the direction of the BF. Under thisconcentrated stress, the hooks will tend to straighten and transition tothe martensitic state, thereby becoming super-elastic. Thus the hooks 40are designed to bend toward a substantially straight configuration asseen, for example in FIG. 9H, when a specific hook migration force isapplied and spring back to their original shape once the hook migrationforce is removed. By virtue of this design, the hooks 40 will tend toleave a small generally circular incision EP in the vessel wall as thehooks are super elastically straightened (without suffering fromcatastrophic failure) during removal rather than a large gash or tear inthe vessel wall, as is the case with known hooks that do not utilize thefeatures discussed herein.

Alternatively, a reduction in temperature below an Af temperature can beapplied to the shape memory material to cause a change in thecrystalline phase of the material so as to render the material malleableduring loading or retrieval of the filter. Various techniques can beused to cause a change in crystalline phase such as, for example, coldsaline, low temperature fluid or thermal conductor.

In another embodiment, shown in FIG. 8A, a dilator 174 and introducersheath 172 (that are similar to the dilator and introducer of FIG. 3)can be interlocked together and operated as a single unit 208. In thisexample, the overall length L13 of the combined unit is about 26 inches;the length L14 of the dilator 174 measured from the base of the fluidinfusion hub to a tip 176 of the dilator is about 24 inches; the lengthL15 of the tapered tip portion of the dilator 174 is about 0.2 inches;the length L16 of the introducer sheath 172 measured from the base ofthe fluid infusion hub to the tip 196 of the sheath is about 21 inches;and the length L17 of the tapered distal portion of the introducersheath is about 0.2 inches. Side ports 194 are provided along the lengthof the distal portion of the dilator such that fluid infused through thedilator 174 may exit the side ports 194 and dilate the blood vessel orprovide contrast agent for real-time imaging of the dilator tip. Thedilator/introducer sheath unit 208 may then be inserted over a suitablesized guidewire into the patient's circulatory system. Once the distalend 196 of the introducer sheath 172 is placed at the desired locationin the blood vessel, the surgeon may disengage the dilator 174 from theintroducer sheath 172 and withdraw the dilator 174 and the guidewirefrom the lumen of the introducer sheath 172.

FIG. 8B illustrates a proximal end of the introducer sheath 186 engagedwith the fluid infusion hub 202 on the delivery catheter 198 so as tointerlock the two devices together. As shown, a block-stop 221 ispositioned within a channel 216 in the delivery hub extension housing218. The block-stop 221 prevents the user from over withdrawal of thepusher member 228. Moreover, the block stop 221 can prevent the pushermember 228 from backing out in the proximal direction during shipping.As shown in FIG. 8B, when the pusher member 228 is fully displaced inthe proximal direction, the stop member 221 abuts the proximal wall ofthe delivery hub extension 218 and prevents further withdrawal of thepusher member 228. Optionally, the stop member 221 may be configuredwith a cross-sectional profile, such as square, that matches the innersurface of the delivery hub extension housing 218 to prevent the pushermember 228 from rotating. This anti-rotational mechanism may beparticularly useful to prevent rotation of the filter and/orentanglement of the legs. However, in a design utilizing a pusher 12,such as the one shown in FIG. 3, an anti-rotational mechanism is notnecessary.

In the preferred embodiments, a kit is provided that includes the filterdelivery system 100 along with instructions IFU for a clinician todeliver the filter to a target site in a host. The instructions ondelivery of the filter can include the following guidelines.

i. A suitable femoral or jugular venous vessel site in the host may beselected. Typically, this is the vessel on either the left or rightside, depending upon the patient's size or anatomy, the clinician'spreference and/or the location of a venous thrombosis.

ii. The site can be nicked with a blade and the vein punctured with asuitable entry needle, such as an 18-gage needle, or trocar.

iii. A suitable guidewire, such as a J-tipped guidewire, is insertedinto the needle and advanced into a distal vena cava or iliac vesselwhere a filter is to be delivered. Once the guidewire is in position,the entry needle is removed from the patient and slipped off theproximal end of the guide wire.

iv. The dilator 18 is inserted into the introducer 16. Then the proximalend of the guidewire is inserted into both the introducer 16 and dilator18. Saline or a suitable bio-compatible fluid is provided to theintroducer valve 16 d to remove air in the introducer 16, and then theassembly is inserted into the patient and advanced along the guidewireuntil it reaches a desired position in the vena cava or iliac vessel.Positioning of the introducer tip 16 a 1 within the vein at the site fordelivering the filter may be confirmed by fluoroscopy, aided by theradio-opaque markers on or within the introducer 16. Contrasting agentor dye can also be provided to the ports 18 d (or 194 of FIG. 8A) of thedilator tube 18 b via the dilator body 18 a to provide for visualimaging of the introducer tip 16 a 1 via suitable fluoroscopic imagingequipment. The guidewire and the dilator 18 can be removed once the useror physician has determined that the introducer tip 16 a 1 is at thedesired location in the vein or vessel.

v. The dilator 18 can be separated from a snap-fit of the introducer 16by bending and pulling the two components. The introducer can be leftwith its tip in the vena cava. Fluid can be introduced into theintroducer via valve 16 d.

vi. The filter 14, which is pre-stored in the catheter sheath 15, can becoupled to the coupling port 16 b via the snap-fitting, and saline canbe permitted to flow through the catheter sheath 15 to provide lubricitybetween various components of the delivery system 100. The saline may bechilled during portions of the procedure. Similarly, the saline may bewarmed during portions of the procedure, such as just prior to releasingthe filter into the vein, to help raise the filter and pusher assembly12 components above the martensitic-to-austenitic transitiontemperature, causing the filter to seek its annealed shape. Theintroducer 16, catheter sheath 15 and elongated pusher assembly 12 arepreferably held in a linear configuration to avoid kinking and minimizefriction. The filter 14 is physically advanced from the catheter sheath15 through the introducer 16 to a position near the distal tip 16 a 1 ofthe introducer 16. The advancement of the filter 14 can be accomplishedby maintaining the introducer 16 stationary while pushing on the handle12 a of the elongated pusher assembly 12 in the distal direction. Thefilter 14 is maintained inside the introducer 16, i.e., undeployed atthis point. Markings on the pusher assembly 12 may permit the clinicianto determine the position of the filter 14 with respect to the end ofthe introducer 16. Additionally, fluoroscopy may be used to track theposition of the filter 14 within the introducer 16 and with respect tothe patient. When the filter hub 50 approaches the distal end of theintroducer 16, the filter is ready to be deployed.

vii. To deploy the filter 14, the elongated pusher assembly 12 and theintroducer hub 16 c are moved relative to each other over a firstpredetermined distance. At this point, the introducer 16 is retractedproximally while the pusher 12 is held in stationary position to allowthe anchor members 14 b 1-14 b 5 to become unconstrained by theintroducer sheath 16 a and free to expand radially. Hooks 40 at the endsof the anchor members 14 b 1-14 b 5 begin to dig or penetrate into theblood vessel wall to maintain the filter 14 at approximately the desiredlocation.

It should be noted that the instructions IFU for the kit could beembodied in any suitable format such as, for example, in paper orelectronic forms (e.g., a web site, PDFs, video or audio).

To recover the filter 14, there are at least three different embodimentsof a recovery device suitable to remove filter 14. The first embodimentis shown in FIGS. 9A-9I whereas the second embodiment is shown in FIGS.10A-10B and the third embodiment is shown in FIGS. 11A-11B. Eachembodiment is discussed in turn below. It should be noted that bothembodiments could be utilized to remove the filter either from a jugularor a femoral approach.

Referring to FIG. 9A, the recovery device 200 a is graphicallyillustrated as being utilized from a jugular approach. Alternatively,the recovery device 200 b can be utilized from a femoral approach,illustrated here based on the direction of blood flow BF in FIG. 9B. Theretrieval device may include first and second generally tubularretrieval sheaths or members 210 and 220 where the first generallytubular member 210 extends from a first end to a second end to define alongitudinal axis A-A extending therethrough, and the second generallytubular member 220 is disposed generally coaxially with the firstgenerally tubular member 210. The retrieval device 200 a may alsoinclude a collapsible member 230 coupled to the second generally tubularmember 220 that defines a portion of a cone in a first configuration(FIG. 9A) and a cylinder (FIG. 9I) in another configuration where aretrieval member 240 is disposed in the second tubular member 220 andthe collapsible member 230. The retrieval member 240 in this embodimentincludes at least one claw 242. Markers M can be provided in at leastone or more of the components described in relation to FIGS. 9A, 10A and11A.

As shown in FIG. 9A, the collapsible member 230 can be configured as aplurality of radially extending members 230 a-230 d connected togethervia a membrane 232 to define a generally truncated cone 234 in adeployed configuration of the retrieval device 200 a. The membrane canbe made from suitable material such as, for example, (and not limitedto) ePTFE, Dacron, polyurethane, polytetrafluoroethylene, nylon, PET,PEBAK, barium sulfate, and combinations thereof. To assist a clinicianin determining the location of the retrieval device in relation to thefilter, a radiopaque marker can be disposed on at least one of thefirst, second and third tubular members.

Retrieval can be performed as follows. In FIG. 9B, the retrieval member240 is maneuvered into position so that it engages the links 30 b 1 and30 b 2 (or 30 a 1 and 30 a 2 if the retrieval device is utilized withthe jugular approach). Instead of a nub, the splined member withretrieval hook 21 (FIG. 6C) can be utilized with a retrieval member inthe configuration of a looped snare, shown for example, in the preferredembodiment of FIGS. 11A-11B. Proximal movement R of the retrieval member240 results in the links being pulled in the proximal direction whichresults in the extraction of hooks 40 from the vessel wall BVW. Theextraction of the hooks 40 generally leaves very small incision openingon the vessel wall that are slightly larger than the cross-sectionalarea of each hook with little or almost no tear or injury to the vesselwall. As the retrieval member 240 is continued to be pulled relative tothe retrieval sheaths (or the retrieval sheaths 210 and 220 are moveddistally while the retrieval member 240 is stationary), shown here inFIGS. 9D and 9E, the filter structure 14 b is converted from a generallyconic configuration towards a generally cylindrical configuration. Thesheaths 210 and 220 are moved distally once the filter structure 14 b isin the cylindrical configuration. The sheaths 210 and 220 continue tomove distally towards filter structure 14 a, shown here in FIGS. 9F and9G. Continued movement of the sheaths 210 and 220 will cause thecollapsible member 230 to engage the anchor members 14 a 1 and 14 a 2(FIGS. 9G and 9H) at which point the membrane 232 or the radiallyextending members 230 a-230 d causes the filter structure 14 a tocollapse into a cylindrical configuration, which causes the hooks 40 tostraighten and explant from the vessel wall with small incision pointsEP. Continued relative movement of the sheaths 210, 220 relative toretrieval member 240 causes the filter 14 to be retracted into thecollapsible member 230. In one preferred embodiment, the entire filter14 and collapsible structure are retracted within the sheath 210 and thesheaths 210 and 220 are removed from the blood vessel.

In the second embodiment illustrated in FIGS. 10A and 10B, the retrievaldevice 200 b includes a third sheath or generally tubular member 250disposed about a portion of retrieval member 240′ where the retrievalmember 240′ includes plurality of claws 244 and 246. Retrieval of thefilter is performed by engaging the claws 244 and 246 against links 30 b1 and 30 b 2. The claws 244, 246 are pulled into the third sheath 250 toforce the claws to move toward each other and thereby capture the linkstherebetween. Once the claws are retracted into the third sheath 250,the third sheath 250 is moved relative to the collapsible member 230(i.e., the sheath 250 can move relative to stationary sheaths 210 and220 or sheaths 210, 220 can move relative to sheath 250). Extraction ofthe filter can be performed in a manner similar to FIGS. 9F-9I.

In the third embodiment illustrated in FIGS. 11A and 11B, the retrievaldevice 200 b includes retrieval member 240″ having a collapsible loopedsnare, such as for example, an Amplatz GOOSE NECK snare from eV3 Inc.,preferably configured to engage the retrieval hook 21 of the filter 14,as shown for example, in FIG. 6C. Retrieval of the filter is performedby engaging the looped snare of the retrieval member 240″ with theretrieval hook 21 of the filter 14. Proximal movement R of the retrievalmember 240″ results in the links being pulled in the proximal directionwhich results in the extraction of hooks 40 from the vessel wall BVW.Extraction of the filter can be performed in a manner similar to FIGS.9F-9I. It should be noted that the three extraction methods describedherein can also be embodied as instructions-for-use with the retrievalsystem as a kit, in somewhat of a similar configuration as the deliverykit.

By virtue of the filter, delivery system and retrieval system describedherein, a method of delivering a filter and extracting such filter canbe provided. In particular, the method allows for delivery of a bloodfilter from either an incision in the femoral or jugular vessels. Themethod can be achieved by providing a filter having first and secondfilter structures that diverge away from a longitudinal axis in oppositedirections in a first configuration and a link connected to discreteportions of each of the first and second filter structures so that eachfilter structure is independently collapsed into a generally cylindricalshape in a second configuration; storing the filter proximate a distalend of a generally tubular sheath having a first end, intermediate endand a second end defining a longitudinal axis extending therethrough,the first end having an inner surface exposed to the longitudinal axis,the inner surface having a plurality of notches formed on the innersurface, the intermediate end including a boss portion coupled to thepusher and disposed in the tubular member having a plurality of groovesformed in the boss portion; accessing an implantation site via one ofthe femoral or jugular vessels; and releasing the filter from the sheathproximate the implantation site to engage the filter structures againsta vessel wall of the implantation site. Retrieval of the filter can beperformed by forming an access to the implantation site via one of thefemoral or jugular vessels; and retrieving the filter into a retrievalsheath. The retrieving can include retracting a portion of at least onehook from one of the filter structures to disengage the hook from thevessel wall.

In another embodiment, bio-active agents can be incorporated with theblood filter or filter delivery system, such as by way of a coating onparts of the filter delivery components (e.g., the pusher member 12 c orthe tip of the introducer sheath 16 a), or dissolvable structures on,within or attached to the filter delivery components. Alternatively,bio-active agents can be delivered to the region of the filter at thetime of the filter emplacement by means of the introducer, either beforeor after delivery of the filter. Bio-active agent can be included aspart of the filter delivery system in order to treat or prevent otherconditions (such as infection or inflammation) associated with thefilter, or to treat other conditions unrelated to the filter itself.More specifically, bio-active agents may include, but are not limitedto:

pharmaceutical agents, such as, for example,anti-proliferative/antimitotic agents including natural products such asvinca alkaloids (i.e. vinblastine, vincristine, and vinorelbine),paclitaxel, epidipodophyllotoxins (i.e. etoposide, teniposide),antibiotics (dactinomycin (actinomycin D) daunorubicin, doxorubicin andidarubicin), anthracyclines, mitoxantrone, bleomycins, plicamycin(mithramycin) and mitomycin, enzymes (L-asparaginase which systemicallymetabolizes L-asparagine and deprives cells which do not have thecapacity to synthesize their own asparagine);

antiplatelet agents such as G(GP) IIb/IIIa inhibitors and vitronectinreceptor antagonists;

anti-proliferative/antimitotic alkylating agents such as nitrogenmustards (mechlorethamine, cyclophosphamide and analogs, melphalan,chlorambucil), ethylenimines and methylmelamines (hexamethylmelamine andthiotepa), alkyl sulfonates-busulfan, nirtosoureas (carmustine (BCNU)and analogs, streptozocin), and trazenes-dacarbazinine (DTIC);

anti-proliferative/antimitotic antimetabolites such as folic acidanalogs (methotrexate), pyrimidine analogs (fluorouracil, floxuridine,and cytarabine), purine analogs and related inhibitors (mercaptopurine,thioguanine, pentostatin and 2-chlorodeoxyadenosine {cladribine});

platinum coordination complexes (cisplatin, carboplatin), procarbazine,hydroxyurea, mitotane, aminoglutethimide;

hormones (i.e. estrogen);

anti-coagulants (heparin, synthetic heparin salts and other inhibitorsof thrombin);

fibrinolytic agents (such as tissue plasminogen activator, streptokinaseand urokinase), aspirin, dipyridamole, ticlopidine, clopidogrel,abciximab;

antimigratory agents;

antisecretory agents (e.g., breveldin);

anti-inflammatory agents, such as adrenocortical steroids (cortisol,cortisone, fludrocortisone, prednisone, prednisolone,6α-methylprednisolone, triamcinolone, betamethasone, and dexamethasone),non-steroidal agents (salicylic acid derivatives i.e. aspirin;

para-aminophenol derivatives i.e. acetominophen;

indole and indene acetic acids (indomethacin, sulindac, and etodalac),heteroaryl acetic acids (tolmetin, diclofenac, and ketorolac),arylpropionic acids (ibuprofen and derivatives), anthranilic acids(mefenamic acid, and meclofenamic acid), enolic acids (piroxicam,tenoxicam, phenylbutazone, and oxyphenthatrazone), nabumetone, goldcompounds (auranofin, aurothioglucose, gold sodium thiomalate);

immunosuppressives: (cyclosporine, tacrolimus (FK-506), sirolimus(rapamycin), azathioprine, mycophenolate mofetil);

angiogenic agents, such as vascular endothelial growth factor (VEGF),fibroblast growth factor (FGF);

angiotensin receptor blockers;

nitric oxide donors;

anti-sense oligionucleotides and combinations thereof;

cell cycle inhibitors, such as mTOR inhibitors, and growth factorreceptor signal transduction kinase inhibitors;

retenoids;

cyclin/CDK inhibitors;

HMG co-enzyme reductase inhibitors (statins); and

protease inhibitors.

Suitable polymer coating materials include polycarboxylic acids,cellulosic polymers, including cellulose acetate and cellulose nitrate,gelatin, polyvinylpyrrolidone, cross-linked polyvinylpyrrolidone,polyanhydrides including maleic anhydride polymers, polyamides,polyvinyl alcohols, copolymers of vinyl monomers such as EVA, polyvinylethers, polyvinyl aromatics, polyethylene oxides, glycosaminoglycans,polysaccharides, polyesters including polyethylene terephthalate,polyacrylamides, polyethers, polyether sulfone, polycarbonate,polyalkylenes including polypropylene, polyethylene and high molecularweight polyethylene, halogenated polyalkylenes includingpolytetrafluoroethylene, polyurethanes, polyorthoesters, proteins,polypeptides, silicones, siloxane polymers, polylactic acid,polyglycolic acid, polycaprolactone, polyhydroxybutyrate valerate andblends and copolymers thereof, coatings from polymer dispersions such aspolyurethane dispersions (for example, BAYHDROL® fibrin, collagen andderivatives thereof, polysaccharides such as celluloses, starches,dextrans, alginates and derivatives, hyaluronic acid, squaleneemulsions. Polyacrylic acid, available as HYDROPLUS® (Boston ScientificCorporation, Natick, Mass.), and described in U.S. Pat. No. 5,091,205,the disclosure of which is hereby incorporated herein by reference inits entirety, is particularly desirable. Another material can also be acopolymer of polylactic acid and polycaprolactone.

While the present invention has been disclosed with reference to certainpreferred embodiments, numerous modifications, alterations, and changesto the described embodiments are possible without departing from thesphere and scope of the present invention, which is described, by way ofexample, in the appended numbered paragraphs below. Accordingly, it isintended that the present invention not be limited to the describedembodiments, but that it have the full scope defined by the language ofat least the following paragraphs, and equivalents thereof.

1. A blood filter comprising: first and second filter structures thatdiverge away from a longitudinal axis in opposite directions in a firstconfiguration of the filter structures; and a link connected to discreteportions of each of the first and second filter structures so that eachfilter structure is independently collapsed into a generally cylindricalshape in a second configuration.
 2. The blood filter of claim 1, whereineach of the first and second filter structures comprises at least twoelongated members.
 3. The blood filter of claim 2, wherein each of theat least two elongated members comprises a single wire having a firstsection defining a portion of the first filter structure, a middlesection disposed proximate the longitudinal axis, and a second sectiondefining a portion of the second filter structure.
 4. The blood filterof claim 3, where the link comprises an elongated member connected tothe first section of each wire of the first filter structure.
 5. Theblood filter of claim 3, wherein the link comprises an elongated memberconnected to the first section of each wire of the second filterstructure.
 6. The blood filter of claim 3, wherein each of the elongatedmembers comprises a tubular member having an open end distal to thelongitudinal axis and a hook having a portion disposed in the open endand connected to the link so that the hook is partially retracted intothe open end when the link is moved axially along the longitudinal axis.7. The blood filter of claim 3, wherein the elongated member includes anend configured to slide on the outer surface of the wire.
 8. The bloodfilter of claim 3, wherein the elongated member includes an end fixedfor rotation about the wire.
 9. The blood filter of claim 3, wherein theelongated member includes an end configured to slide and rotate withrespect to the wire.
 10. The blood filter of claim 9, further comprisinga boss connected to the link member.
 11. The blood filter of claim 9,further comprising a hub disposed about the middle portion of each wire.12. The blood filter of claim 11, wherein the first filter structurecomprises a retention member disposed at one terminal end of each wire.13. The blood filter of claim 12, wherein the retention member comprisesan anchor.
 14. The blood filter of claim 13, wherein the anchorcomprises a hook having a material selected from a group consistingessentially of shape memory material, super-elastic material,linear-elastic material, metal, alloys, polymers and combinationsthereof.
 15. The blood filter of claim 14, wherein the wire comprises amaterial selected from a group consisting essentially of shape memorymaterial, super-elastic material, linear-elastic material, metal,alloys, polymers and combinations thereof.
 16. The blood filter of claim14, wherein the hook comprises a curved configuration in an operativecondition and a generally linear configuration in another condition. 17.(canceled)
 18. (canceled)
 19. The blood filter of claim 4, wherein thelink comprises an elongate member unitary with a coupling.
 20. The bloodfilter of claim 19, wherein the coupling comprises a super elastichinge.
 21. A delivery catheter sheath for a blood filter comprising: agenerally tubular member having a first end, intermediate end and asecond end defining a longitudinal axis extending therethrough, thefirst end having an inner surface exposed to the longitudinal axis, theinner surface having a plurality of notches formed on the inner surface,the intermediate end including a boss portion disposed in the tubularmember having a plurality of grooves formed in the boss portion.
 22. Thedelivery catheter sheath of claim 21, further comprising a body coupledat one end to the second end of the sheath and an elongated membercoupled to the boss portion, the elongated member extending out ofanother end of the body to provide a handle.
 23. The delivery cathetersheath of claim 22, wherein the body comprises a Y-adapter.
 24. Thedelivery catheter sheath of claim 22, further comprising marker disposedproximate the first end of the sheath.
 25. The delivery catheter sheathof claim 24, wherein the elongated member comprises a generallycylindrical member having at least two different cross-sectional areasproximate the handle.
 26. The delivery catheter sheath of claim 25,wherein the body comprises a snap-fit boss formed on an outer surface ofthe Y-adapter proximate the second end of the catheter sheath.
 27. Thedelivery catheter sheath of claim 22, wherein the sheath comprises apolymeric tube having at least two different Shore durometer of hardnessproximate one of the first and second ends.
 28. The delivery cathetersheath of claim 22, wherein each groove of the plurality of groovescomprises a plurality of widths along a length of the groove.
 29. Thedelivery catheter sheath of claim 22, further comprising at least oneanchor portion of a filter located in at least one of the plurality ofgrooves, the anchor portion having a maximum width greater than aminimum width of the groove.
 30. A blood filter retrieval devicecomprising: a first generally tubular member that extends from a firstend to a second end to define a longitudinal axis extendingtherethrough; a second generally tubular member disposed generallycoaxially with the first generally tubular member; a collapsible membercoupled to the second generally tubular member that defines a portion ofa cone in one configuration and a general cylindrical shape in anotherconfiguration; and a retrieval member disposed in the second tubularmember and the collapsible member.
 31. The retrieval device of claim 30,further comprising a third generally tubular member disposed about aportion of the retrieval member.
 32. The retrieval device of claim 30,wherein the retrieval member comprises a plurality of claws.
 33. Theretrieval device of claim 30, wherein the retrieval member comprises anelongated member coupled to at least one claw.
 34. The retrieval deviceof claim 33, wherein the collapsible member comprises a plurality ofradially extending member connected together via a membrane to define agenerally truncated cone.
 35. The retrieval device of claim 34, whereinthe membrane comprises a material selected from a group consistingessentially of polyurethane, polytetrafluoroethylene, nylon, PET, PEBAK,barium sulfate, and combinations thereof.
 36. The retrieval device ofclaim 34, further comprising a radiopaque marker disposed on at leastone of the first, second and third tubular members.
 37. A blood filtersystem comprising: an introducer having a coupling port connected to anelongated generally tubular member; a pusher assembly having a first enddisposed in the storage member and a second end extending out of theY-adapter, the pusher assembly including: a handle disposed along alongitudinal axis of the pusher assembly proximate the second end; apusher disposed along the longitudinal axis proximate the first end ofthe elongated assembly; and a generally tubular member having a firstend, intermediate end and a second end defining a longitudinal axisextending therethrough, the first end having an inner surface exposed tothe longitudinal axis, the inner surface having a plurality of notchesformed on the inner surface, the intermediate end including a bossportion coupled to the pusher and disposed in the tubular member havinga plurality of grooves formed in the boss portion, the first end coupledto the Y-adapter; and a blood filter including: at least a first anchormember having hooks disposed in one of the grooves and notches; and atleast a second anchor member having hooks disposed in the other of thegrooves and notches.
 38. The system of claim 37, wherein each groove ofthe plurality of grooves comprises a plurality of widths along a lengthof the groove.
 39. The system of claim 38, wherein the hook comprises amaximum width greater than a minimum width of the groove.
 40. A bloodfilter kit comprising: a delivery system including: an introducer havinga coupling port connected to an elongated generally tubular member; adilator configured to be inserted into the introducer to dilate avessel; a pusher assembly having a first end disposed in the storagemember and a second end extending out of the Y-adapter, the pusherassembly including: a handle disposed along a longitudinal axis of thepusher assembly proximate the second end; a pusher member disposed alongthe longitudinal axis proximate the first end of the elongated assembly;and a generally tubular member having a first end, intermediate end anda second end defining a longitudinal axis extending therethrough, thefirst end having an inner surface exposed to the longitudinal axis, theinner surface having a plurality of notches formed on the inner surface,the intermediate end including a boss portion coupled to the pusher anddisposed in the tubular member having a plurality of grooves formed inthe boss portion, the first end coupled to the Y-adapter; a blood filterincluding: at least a first anchor member having hooks disposed in oneof the grooves and notches; at least a second anchor member having hooksdisposed in the other of the grooves and notches; and a human readablegraphical and textual instruction on how to deliver the blood filter toa site in format using the delivery device.
 41. The kit of claim 40,further comprising a retrieval device including: a first generallytubular member that extends from a first end to a second end to define alongitudinal axis extending therethrough; a second generally tubularmember disposed generally coaxially with the first generally tubularmember; a collapsible member coupled to the second generally tubularmember that defines a portion of a cone in one configuration and acylinder in another configuration; a retrieval member disposed in thesecond tubular member and the collapsible member; and a human readablegraphical and textual instruction on how to retrieve the blood filter.42. A method of delivering a blood filter from either an incision in thefemoral or jugular vessels, the method comprising: providing a filterhaving first and second filter structures that diverge away from alongitudinal axis in opposite directions in a first configuration and alink connected to discrete portions of each of the first and secondfilter structures so that each filter structure is independentlycollapsed into a generally cylindrical shape in a second configuration;storing the filter proximate a distal end of a generally tubular sheathhaving a first end, intermediate end and a second end defining alongitudinal axis extending therethrough, the first end having an innersurface exposed to the longitudinal axis, the inner surface having aplurality of notches formed on the inner surface, the intermediate endincluding a boss portion coupled to the pusher and disposed in thetubular member having a plurality of grooves formed in the boss portion;accessing an implantation site via one of the femoral or jugularvessels; and releasing the filter from the sheath proximate theimplantation site to engage the filter structures against a vessel wallof the implantation site.
 43. The method of claim 42, further comprisingretrieval of the blood filter by: forming an access to the implantationsite via one of the femoral or jugular vessels; and retrieving thefilter into a retrieval sheath.
 44. The method of claim 43, wherein theretrieving comprises retracting a portion of at least one hook from oneof the filter structures to disengage the hook from the vessel wall.